Chemotherapy + Immunotherapy for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you should avoid using potent CYP3A4 inhibitors like ketoconazole and erythromycin during the study. Participants on bisphosphonates can continue their therapy.
What data supports the effectiveness of the drug combination of nab-paclitaxel and pembrolizumab for breast cancer?
Nab-paclitaxel, a component of the treatment, has shown significant effectiveness in treating metastatic breast cancer, with rapid and dramatic tumor responses in patients with poor prognostic factors. Additionally, it is approved for use in metastatic breast cancer due to its superior therapeutic index compared to conventional paclitaxel.12345
Is the combination of chemotherapy and immunotherapy safe for breast cancer treatment?
Nab-paclitaxel (Abraxane) has been studied for safety in various cancers, including breast cancer, and is generally considered safe, though it can cause side effects like any chemotherapy. It is a special form of paclitaxel that is designed to be easier on the body, and studies have shown it to be well-tolerated in patients with different types of cancer.12678
What makes the drug combination of Nab-Paclitaxel and Pembrolizumab unique for breast cancer treatment?
This drug combination is unique because Nab-Paclitaxel is a novel formulation of paclitaxel that doesn't require toxic solvents, making it safer and potentially more effective by increasing drug concentration in tumors. Pembrolizumab, an immunotherapy, works by helping the immune system recognize and attack cancer cells, offering a dual approach by combining chemotherapy and immunotherapy.135910
What is the purpose of this trial?
This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for hormone receptor positive breast cancer.The interventions involved in this study are:* Pembrolizumab (MK-3475; Keytruda™)* Nab-Paclitaxel (Abraxane
Research Team
Adrienne Gropper Waks, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults with hormone receptor-positive, HER2-negative operable breast cancer larger than 2 cm without distant metastasis. They must not have had prior treatments for this cancer and agree to use contraception. Participants need normal organ/marrow function, no active autoimmune diseases or infections, and can't be on systemic steroids/immunosuppressants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nab-Paclitaxel and Pembrolizumab. Nab-Paclitaxel is administered weekly and Pembrolizumab every 3 weeks for a total of 14-15 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in PD-L1 expression and overall response rate.
Long-term Follow-up
Participants are monitored for disease-free survival and other long-term outcomes.
Treatment Details
Interventions
- Biopsy
- Nab-Paclitaxel
- Pembrolizumab
Nab-Paclitaxel is already approved in United States, European Union, Canada for the following indications:
- Breast cancer
- Pancreatic cancer
- Non-small cell lung cancer
- Breast cancer
- Pancreatic cancer
- Breast cancer
- Pancreatic cancer
- Non-small cell lung cancer
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Adrienne G. Waks
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University